NDC Code(s) : 71014-001-01, 71014-001-02
Packager : Eai-Jr286, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Elemental Resestance Broad Spectrum SPF 50 Octyl Methoxycinnamate, Oxybenzone, Titanium Dioxide, Zince Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71014-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE6 g in 100 g
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE5 g in 100 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE6.3 g in 100 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION9.9 g in 100 g
Inactive Ingredients
Ingredient Name Strength
AMMONIA(UNII: 5138Q19F1X)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
IODOPROPYNYL BUTYLCARBAMATE(UNII: 603P14DHEB)
LAURYL PEG/PPG-18/18 METHICONE(UNII: ZJ5S27D9NX)
METHYL GLUCOSE DIOLEATE(UNII: FA9KFJ4Z6P)
METHYLCHLOROISOTHIAZOLINONE(UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE(UNII: 229D0E1QFA)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
WATER(UNII: 059QF0KO0R)
SILICA DIMETHYL SILYLATE(UNII: EU2PSP0G0W)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM DODECYLBENZENESULFONATE(UNII: 554127163Y)
STEARIC ACID(UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71014-001-021 in 1 BOX 07/10/2016
1NDC:71014-001-0180 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 10/07/2016

PRINCIPAL DISPLAY PANEL

Vertra

Elemental Resistance

SunProtectionCReam

Broad Spectrum SPF 50+

 UVA/UVB Protection

Water Resistant (80 minutes)

Net Wt. 2.8oz (80g)

Box